56 Participants Needed

Flourish Vaginal Care System for Neovaginal Microbiome Health

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sexual Health and Wellness Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines if a store-bought vaginal health kit, called the Flourish Vaginal Care System, can help transgender women who have had gender-confirming surgery develop a healthy vaginal environment. The kit aims to promote good bacteria, similar to what is found in healthy cisgender women. The goal is to improve overall vaginal health and satisfaction for these women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the Flourish Vaginal Care System safe for human use?

A study on a similar intravaginal system with DL-lactic acid showed no irritation or adverse events in a small group of healthy women, suggesting it may be safe for human use.12345

How is the Flourish Vaginal Care System treatment different from other treatments for neovaginal microbiome health?

The Flourish Vaginal Care System is unique because it likely focuses on using probiotics, specifically lactobacilli, to maintain a healthy vaginal microbiome, which is different from traditional antibiotic treatments. This approach leverages the natural role of lactobacilli in acidifying the vaginal environment and inhibiting harmful microorganisms, offering a potentially safer and more natural alternative.16789

What data supports the effectiveness of the Flourish Vaginal Care system treatment for neovaginal microbiome health?

Research suggests that promoting Lactobacillus colonization with probiotics can help maintain a healthy vaginal microbiome, which is important for women's reproductive health. Although specific data on the Flourish Vaginal Care system is not available, similar treatments using probiotics have shown potential benefits in managing the vaginal microbiome.19101112

Who Is on the Research Team?

CM

Christine McGinn, DO

Principal Investigator

Papillon Center

Are You a Good Fit for This Trial?

This trial is for healthy cisgender women aged 18-52 and transgender women over age 18 who are planning to have gender-confirmation surgery. Participants should not be allergic to aloe vera or components of the Flourish Vaginal Care system, nor have certain infections or immune suppression.

Exclusion Criteria

My immune system is weakened.
I have a vaginal infection that is not yeast or BV.
I cannot tolerate Restore gel after my surgery.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Flourish Vaginal Care System or standard care for 6 months to establish a neovaginal microbiome

6 months
Collections at time 0, 6 weeks, and 6 months

Follow-up

Participants are monitored for changes in vaginal pH and microbiome composition after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Flourish Vaginal Care system
Trial Overview The study is testing the Flourish Vaginal Care System's ability to establish a healthy microbiome in neovaginas of transgender women post-surgery, using commercially-available wellness products.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Group 3: Cisgender womenExperimental Treatment1 Intervention
Group II: Group 1: Transgender women using FlourishExperimental Treatment1 Intervention
Group III: Group 2: Transgender women not using FlourishActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sexual Health and Wellness Institute

Lead Sponsor

Trials
9
Recruited
170+

Vaginal Biome Science

Lead Sponsor

Trials
10
Recruited
3,400+

Papillon Center

Collaborator

Trials
1
Recruited
60+

Published Research Related to This Trial

In a pilot study involving 43 healthy premenopausal women, a 10-strain probiotic formulation significantly reduced vaginal pH, indicating potential benefits for vaginal health, particularly in those with intermediate Nugent scores or elevated pH levels.
The probiotic was well tolerated with high compliance, and while it did not significantly change Nugent scores, it maintained lactobacilli abundance, suggesting a positive impact on vaginal microbiota.
Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study.Martoni, CJ., Frederiksen, AKS., Damholt, A., et al.[2022]

Citations

Probiotic treatment with specific lactobacilli does not improve an unfavorable vaginal microbiota prior to fertility treatment-A randomized, double-blinded, placebo-controlled trial. [2023]
The effect of probiotic supplementation during pregnancy on the interaction network of vaginal microbiome. [2021]
Cervicovaginal Microbiota and Reproductive Health: The Virtue of Simplicity. [2022]
Complexities of the uniquely human vagina. [2012]
The vaginal microbiome in health and disease. [2021]
Twice-daily application of HIV microbicides alter the vaginal microbiota. [2021]
Characterization of the Ovine Vaginal Microbiome and Inflammation Patterns as an Improved Testing Model of Human Vaginal Irritation. [2022]
Optimal sampling and analysis methods for clinical diagnostics of vaginal microbiome. [2023]
Rationale and Safety Assessment of a Novel Intravaginal Drug-Delivery System with Sustained DL-Lactic Acid Release, Intended for Long-Term Protection of the Vaginal Microbiome. [2022]
Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study. [2022]
Use of probiotic lactobacilli in the treatment of vaginal infections: In vitro and in vivo investigations. [2023]
Integrating compositional and functional content to describe vaginal microbiomes in health and disease. [2023]
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